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Completed

NCT Number: NCT01825928

An Study of Paliperidone Extended-Release Tablets in the Treatment of Methamphetamine Dependence

Methamphetamine substance use is common worldwide. No approved pharmacologic treatments for methamphetamine dependence exist. paliperidone are Second generation antipsychotics，and have effects of blocking dopamine2(D2) and 5-hydroxytryptamine 2A(5-HT) receptors neurotransmitters.To determine whether mirtazapine would reduce methamphetamine use among methamphetamine addicts.

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Key information

Conditions

Methamphetamine Dependence

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Second Xiangya Hospital of Central University

Changsha, Hunan, 410011, China

About this study

Methods:A Multiple-Center, Randomized, Double-Blind.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men and women aged 18 years to 60 years
  • Met the Diagnostic and Statistical Manual of Mental Disorders 4th edition (DSM-IV) criteria for METH dependence with psychosis
  • Completing inpatient METH detoxification (≤30 days) with psychotic symptoms disappeared
  • Beoff any anti-psychotic medication for 7 days after discharging from hospital were enrolled at clinical site
  • Participants were interesting in reducing or stopping METH use
  • Every patient also had a significant other (eg., spouse or relative) who supervised their compliance with the visit schedule and study procedures
  • Women of childbearing potential agreed to use contraception during the study.

Exclusion criteria

  • Pregnancy or breastfeeding;
  • Significant medical conditions (eg., acute renal failure, endocarditis, and tuberculosis); hepatic failure; past or present history of an AIDS-indicator disease; active hepatitis or aspartate amino transferase or alanine aminotransferase more than three times the upper limit of normal
  • Known intolerance or hypersensitivity to paliperidone ER; other psychosis; present dependence on substances other than METH or poly-substance abuse.

Treatment and study plan

Paliperidone

Drug

Paliperidone group,3mg/pill,3mg/day forced titration method,last 84 days

Other names: Paliperidone Extended-Release Tablets, Invega

Placebo

Drug

placebo group,3mg/pill,3mg/day forced titration method,last 84 days

Primary outcomes

  1. Abstinent time of Methamphetamine addict

    Time frame: up to 84 days

    The outcome was the confirmed abstinence during 12 weeks. Confirmed abstinence was defined as a negative urine drug test. The following aggregate measures of urine drug test results were calculated: the time-to-first positive urine test, the Treatment Effectiveness Score (TES; the sum of the number of METH-free urine samples submitted per participant ), the longest period of MA abstinence during the 84 days.

Secondary outcomes

  1. Time (day) to first psychosis relapse from baseline to 84 days

    Time frame: up to 84 days

    psychosis assessement was made once a week.Psychotic symptom relapse was defined as one or more of the following: (1) hospitalization for psychotic symptoms; deliberate self-injury or violent behavior, or suicidal or homicidal ideation that was clinically significant;25% increase in PANSS total score;for patients who scored >40 at randomization, or a 10-point increase for patients who scored ≤40 at randomization for two consecutive assessments (within 1 week), and (4) increase in prespecified individual PANSS items scores (P1, P2, P3, P6, P7 and G8) to ≥5 for patients whose score was ≤3 at randomization, or to ≥6 for patients whose score was 4 at randomization for two consecutive assessments (within 1 week)

  2. Change from baseline in CGI-S scores at 84 days

    Time frame: up to 84 days

    general condition assessment was made by CGI-S once a week, and calculated the total scores

  3. Change from baseline in Visual Analogue Scale (VAS) at 84 days

    Time frame: up to 84 days

    Methamphetamine craving assessment was made by VAS once a week, and calculated the total scores

  4. number of treatment day which calculated from randomization to the last visiting point

    Time frame: up to 84 days

    record the follow up time

Sponsors and collaborators

Lead sponsor

Wei Hao

Other

Registry information

Official study title

Randomized, Double-blind, Placebo-controlled Trial of Paliperidone Extended-Release Tablets for The Treatment of Methamphetamine Dependence in Chinese Patients After Detoxification

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Apr 8, 2013
Registry last updated
Jul 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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